Directional Deep Brain Stimulation in Advanced Parkinson's Disease - Clinical Review
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The actual use of directional DBS stimulation in everyday life during the follow-up
研究概览
简要总结
The aim of the study is to assess the clinical outcome in patients with Parkinson's disease treated with directional deep brain stimulation (dDBS). The patients have been selected for the dDBS treatment by their treating neurologist. The study is a registry-based follow-up study.
详细描述
The study group consists of patients with advanced Parkinson's disease treated with directional deep brain stimulation in Helsinki University Hospital between 2017 - 2020. The study is a registry-based follow-up study. The aim of the study is to assess the clinical outcome and possible adverse effects of the dDBS treatment. The data will be collected from the patient records. The observed time points are 6-month's, 12-month's and 18-month's postoperative visits.
The following data will collected: the scores of Unified Parkinson's disease questionnaire part III (UPDRS-III), Non-Motor Symptoms Questionnaire (NMS-quest), Beck Depression Inventory (BDI), Mini-Mental State Examination (MMSE), Abnormal Involuntary Movement Scale (AIMS) evaluated in the screening phase for dDBS treatment and at 6-months' follow-up. Possible levodopa equivalent dose changes, LEDDs, will also be assessed at these time points.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced Parkinson's disease and treated with directional deep brain stimulation
排除标准
- •patients with advanced Parkinson's disease and not treated with directional deeb brain stimulation
结局指标
主要结局
The actual use of directional DBS stimulation in everyday life during the follow-up
时间窗: 6-18 months
The use of directionality in DBS in patients with PD in everyday life
次要结局
- Evaluation of the dDBS parameters(6 months to 18 months)
- The changes of UPDRS part III score during the DBS treatment(From the initiation of DBS treatment to 18-month's postoperative visit)
- Possible adverse effects(6 months-18 months)
- LEDDs(From preoperative visit to 18 month's postoperative visit)
研究者
Maija Koivu
M.D., Specialist in Neurology
Hospital District of Helsinki and Uusimaa